Some drug recalls involving serious and potentially life-threatening problems appear to be slipping through the cracks, with federal regulators often failing to adequately notify doctors and patients, according to the findings of a new study.
A research letter published in the Archives of Internal Medicine points out what appear to be flaws in the FDA’s notification system for “Class I” drug recalls, which is the most serious category for recalled medications, reserved for drugs with problems that are likely to cause severe injury or death if used.
The FDA is supposed to issue notifications for Class I drug recalls through its Recall Alert System and its MedWatch adverse event reporting system. However, researchers looked at 1,700 drug recalls issued between 2004 and 2011, finding about one major recall per month. They determined that 91 of those were Class I recalls, but not all were reported.
Of the 91 Class I recalls, the Recall Alert System only issued notices for 55 of them. MedWatch did somewhat better, issuing notices for 18 of the remaining 36 that were classified as Class I. That leaves another 18, about one-fifth, that were not reported to doctors by any FDA system.
FDA officials were at a loss to explain the discrepancies, but indicate that they are working on improving their reporting systems, according to a report by Reuters Health.
Researchers note that not only is incompleteness of the warnings a problem, but doctors also may have trouble distinguishing which ones are important and which are not, since both systems try to report every drug recall. For example, veterinary drug recalls are reported in the same manner as Class I drugs, which may pose lethal risks for humans.
“Equally problematic, the Class I recalls that are communicated through the Recall Alert System become buried in a system that is also used for recalls that have little or no bearing on patient care,” the researchers determined. “It may be difficult for providers who subscribe to and rely on these alerting systems to identify those recalls that are of particular importance.”
The researchers called for a comprehensive new strategy for ensuring that health care providers are duly notified when there are clinically important drug recalls.
Tags: Drug Recall